EPILIM CHRONOSPHERE 750 Milligram Granules Prolonged Release

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

VALPROATE SODIUM VALPROIC ACID

Доступно од:

Sanofi-Aventis Ireland Limited T/A SANOFI

INN (Међународно име):

VALPROATE SODIUM VALPROIC ACID

Дозирање:

750 Milligram

Фармацеутски облик:

Granules Prolonged Release

Тип рецептора:

Product subject to prescription which may be renewed (B)

Статус ауторизације:

Authorised

Датум одобрења:

0000-00-00

Информативни летак

For Sanofi
 -Aventis use onl
y
Technica
l Da
ta
Modifica
tions
ID number:   
457234
Version and Date: 
V2 - 22/11/2012
Previous ID number: 
439389
Product type: 
FOLDED LEAFLET
Product name: 
Epilim
Country:  
IE
Artwork by:   
Vincent PÉTIN
Plant:  
AMILLY 
PHARMA
Format: 180 x 336 mm - Folded 60 x 84mm
Number of colors: 1
■
 PMS REFL EX BLUE U
Minimum point size of text: 8 pt
Space between lines: 8,9 pt
Narrowed: 100 %
Fonts: Ocean Sans Pro SAN - C39P24N
Native fi le: In Design CS5
Layout of cutting: AY_NPI_180 x 336_A_2
_PACKAGING TEAM_
V1 - 10/05/2012: New regulatory text + New logo.
V2 - 22/11/2012: Corrections.
RAD001 (10 PISTES) / SCHMUCKER / RAD002 (1 PISTE) GRANDS FORMATS
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPILIM® CHRONOSPHERE® 100MG PROLONGED RELEASE GRANULES
EPILIM® CHRONOSPHERE® 250MG PROLONGED RELEASE GRANULES
EPILIM® CHRONOSPHERE® 500MG PROLONGED RELEASE GRANULES
EPILIM® CHRONOSPHERE® 750MG PROLONGED RELEASE GRANULES
EPILIM® CHRONOSPHERE® 1000MG PROLONGED RELEASE GRANULES
SODIUM VALPROATE AND VALPROIC ACID
IS THIS LEAFL ET HARD TO SEE OR READ? PHONE 
01 4035600 FOR HELP
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
• Keep this leafl et. You may need to read it again.
• If you have further questions, please ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. 
It may harm them even if their symptoms are the same as yours.
• If any of the side eff ects gets serious, or if you notice
any side eff ects 
not listed in this leafl et, please tell your doctor or pharmacist.
IN THIS LEAFL ET:
1.What Epilim Chronosphere is and what it is used for
2. Before you take Epilim Chronosphere
3. How to take Epilim Chronosphere
4. Possible side eff ects
5. How to store Epilim Chronosphere
6. Further information
1. WHAT EPILIM CHRONOSPHERE IS AND WHAT IT IS USED FOR
WHAT EPILIM CHRONOSPHERE IS
The name of your medicine is Epilim Chronosphere 50, 100, 250, 500, 
750

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epilim Chronosphere 750mg prolonged-release granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of prolonged-release granules contains:
Sodium valproate
500.06 mg
Valproic acid
217.75 mg
Equivalent to 750 mg sodium valproate.
For a full list excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release granules.
Sachets containing small, off-white to slightly yellow, waxy microgranules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of generalised, partial or other epilepsy.
Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated. The continuation of
treatment after manic episode could be considered in patients who have responded to Epilim Chronosphere for acute
mania.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Epilim Chronosphere is a pharmaceutical form particularly suitable for children (when they are able to swallow soft
food) and adults with swallowing difficulties.
Epilim Chronosphere is a controlled release formulation of Epilim, which reduces peak concentration and ensures more
regular plasma concentration throughout the day.
Epilim Chronosphere may be given once or twice daily.
In patients where adequate control has been achieved, Epilim Chronosphere formulations are interchangeable with
other conventional or prolonged-release formulations of Epilim on an equivalent daily dosage basis.
Daily dosage should be established according to age and body weight and should be given to the nearest whole 50mg
sachet. Partial sachets should not be used. However, the wide individual sensitivity to valproate should also be
considered.
A good correlation has not been established between daily dose, serum concentration and therapeutic effect, and
optimum dosag